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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

RecruitingPhase 3Ages 18 Years - 80 YearsAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF) * Biopsy-confirmed MASH with fibrosis stage F2 or F3 * Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants). Key Exclusion Criteria: * Chronic liver diseases other than MASH * Evidence of cirrhosis on screening liver biopsy * Have type 1 diabetes or poorly controlled type 2 diabetes * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L) * Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening Other inclusion and exclusion criteria may apply.
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What it tests

  • Pegozafermin
  • Placebo
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Where

370 sites
89bio Clinical Study Site
Birmingham, United States
89bio Clinical Study Site
Chandler, United States
89bio Clinical Study Site
Flagstaff, United States
89bio Clinical Study Site
Glendale, United States
89bio Clinical Study Site
Sun City, United States
89bio Clinical Study Site
Tucson, United States
89bio Clinical Study Site
Tucson, United States
89bio Clinical Study Site
Conway, United States

…and 362 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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